Catalog Number 121881752 |
Device Problem
Fracture (1260)
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Patient Problems
Fall (1848); Joint Laxity (4526)
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Event Date 02/06/2023 |
Event Type
malfunction
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Event Description
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It was reported "patient had a near fall during her inpatient stay.When breaking the fall, she noticed a distinct crack on her newly operated hip.There was likely a momentary subluxation.On postoperative x-ray, a chipped piece of ceramic fragment can be seen.".
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Manufacturer Narrative
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Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device product code: 121881752, lot number: 3954560 and no non-conformances/manufacturing irregularities were identified.Device history review: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.
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Search Alerts/Recalls
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